`SECURITIES AND EXCHANGE COMMISSION
`Washington, D.C. 20549
`
`FORM 8-K
`
`CURRENT REPORT
`
`PURSUANT TO SECTION 13 OR 15(d) OF THE
`SECURITIES EXCHANGE ACT OF 1934
`
`Date of report: January 3, 2005
`Date of earliest event reported: December 31, 2004
`
`PFIZER INC.
`(Exact name of registrant as specified in its charter)
`
`Delaware
`(State or other Jurisdiction of incorporation)
`235 East 42nd Street
`New York, New York
`(Address of principal executive
`offices)
`
`
`
`1-3619
`(Commission File
`Number)
`
`13-5315170
`(I.R.S. Employer Identification
`No.)
`
`10017
`(Zip Code)
`
`Registrant's telephone number, including area code:
`
`(212) 573-2323
`
`Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the obligation of the registrant under any of the
`following provisions:
`
`[ ] Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
`
`[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
`
`[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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`[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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`
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`Item 8.01
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`Other Events
`
`On December 31, 2004, Pfizer Inc. issued a press release announcing that it has received approval from the U.S. Food and Drug
`Administration to market Lyrica™ (pregabalin capsules) for the management of neuropathic pain associated with diabetic peripheral
`neuropathy and postherpetic neuralgia. A copy of the press release is included as Exhibit 99 to this report and is incorporated herein by
`reference.
`
`Item 9.01 Financial
`Statements and Exhibits
`(c) Exhibits
`Exhibit 99
`
`
`
`
`
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`Press Release of Pfizer Inc. dated December 31, 2004.
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`SIGNATURE
`
`Under the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the
`authorized undersigned.
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`Depomed Exhibit 2060, Page 1 of 3
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`Dated: January 3, 2005
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`PFIZER INC.
`
`By: /s/ Margaret M. Foran
`Margaret M. Foran
`Title: Vice President-Corporate
`Governance and Secretary
`
`
`
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`EXHIBIT INDEX
`
`Exhibit No.
`
`99
`
`Description
`
`Press Release of Pfizer Inc. dated December 31, 2004.
`
`Depomed Exhibit 2060, Page 2 of 3
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`
`
`For immediate release:
`December 31, 2004
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`
`
`Exhibit 99
`
`
`Contact: Mariann Caprino
`(212) 733-4554
`
`FDA APPROVES PFIZER’S LYRICA™ FOR THE TREATMENT OF
`THE TWO MOST COMMON FORMS OF NEUROPATHIC (NERVE) PAIN
`
`NEW YORK, December 31, 2004 - Pfizer Inc said today that it has received approval from the U.S. Food and Drug Administration (FDA) to
`market Lyrica™ (pregabalin capsules) for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) and
`postherpetic neuralgia (PHN). Lyrica is the first FDA-approved treatment for both of these neuropathic pain states, which are distinctly
`different from arthritis or musculoskeletal pain.
`
`Developed by Pfizer, Lyrica has a newly defined mechanism of action. Lyrica will be available to physicians and patients in the near future.
`
`“Lyrica is an important new therapy for millions of people suffering from the two most common neuropathic pain conditions as it provides
`rapid and sustained pain relief,” said Dr. Joseph Feczko, president of Worldwide Development at Pfizer. “Lyrica also represents a major
`achievement in Pfizer’s research program and confirms our leadership in bringing life-changing medicines to patients.”
`
`Neuropathic pain, one of the most debilitating forms of pain, is caused by nerve damage that can result from underlying conditions, such as
`diabetes or shingles. Nearly half of the 18 million Americans with diabetes will develop some form of diabetic neuropathy over the course of
`their disease and about one in six diabetes patients will experience painful diabetic neuropathy. The pain of DPN is often described as
`burning, tingling, sharp, stabbing, or pins and needles in the feet, legs, hands or arms.
`
`PHN is a complication of shingles, a painful outbreak of rash or blisters on the skin caused by a reactivation of the same virus that causes
`chicken pox. Each year, about 150,000 Americans develop PHN, which is often characterized as constant stabbing, burning, or electric shock-
`like sensation.
`
`The efficacy of Lyrica was established in six double-blind, placebo-controlled trials, three involving patients with DPN and three involving
`patients with PHN. Lyrica provided rapid and clinically meaningful pain reduction in a significant portion of patients, with pain relief beginning
`as early as the first week of treatment in some patients. Pain relief was sustained in studies of up to 12-weeks duration.
`
`The safety of Lyrica was established in over 9,000 patients. In all clinical trials, adverse events were mild to moderate. The most common
`side effects associated with Lyrica compared with placebo included dizziness, somnolence, dry mouth, peripheral edema, blurred vision,
`weight gain and difficulty with concentration/attention. The discontinuation rate due to side effects was low.
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`Lyrica is expected to be classified as a controlled substance in a category with lower potential for misuse or abuse relative to controlled
`substances in other categories.
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`Lyrica is currently under review by the FDA for the adjunctive treatment of partial seizures in adults. In July, Pfizer received European
`Commission approval to market Lyrica in European Union member states for the treatment of peripheral neuropathic pain and as adjunctive
`therapy for partial seizures.
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`# # # # #
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`DISCLOSURE NOTICE: The information contained in this release is as of December 31, 2004. The Company assumes no obligation
`to update any forward-looking statements contained in this release as a result of new information or future events or developments.
`
`This release contains forward-looking information about Lyrica that involves substantial risks and uncertainties. Such risks and
`uncertainties include, among other things, the controlled substance category in which Lyrica is classified, and the speed with which
`the product launch may be achieved, including the potential for difficulties or delays in manufacturing and marketing. A further list
`and description of risks and uncertainties can be found in the Company's Annual Report on Form 10-K for the fiscal year ended
`December 31, 2003 and in its reports on Forms 10-Q and 8-K.
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`Depomed Exhibit 2060, Page 3 of 3